This searchable database includes PMRs and 506B PMCs which are those studies and trials for clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology. It also includes all open PMRs and 506B PMCs and only those closed (released or fulfilled) within the last year.

Update frequency: Quarterly; generally, on or around the end of January, April, July, and October

Additional PMR/PMC Resources:

Introduction |  Reports |  Legislative Background |  FAQ |  Status and Fulfillment Categories |  Downloadable Database File

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For technical questions about the quarterly updates to the PMR/PMC Searchable Database and Downloadable File: pmcweb@fda.hhs.gov